Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis
- Registration Number
- NCT02699892
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). Protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab will be administered at the discretion of treating physician according to approved label.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
-Participants receiving rituximab no longer than 4 weeks before the start of monitoring
-Not Applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rheumatoid arthritis participants Rituximab Participants who were on rituximab for rheumatoid arthritis and who will continue receiving rituximab treatment (at the discretion of treating physician) according to previous approved indication will be observed for a period of 72 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion Baseline, 24 weeks after first rituximab infusion (Week 24) DAS28 score is a measure of participant's disease activity calculated using tender joint count \[28 joints\] (TJC28), swollen joint count \[28 joints\] (SJC28), participant's global assessment of disease activity (PGH) \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: \[0.56 multiplied by (\*) square root (√) of TJC\] plus (+) \[0.28\*√SJC\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*PGH\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\</=) 3.2 indicated low disease activity, score of greater than (\>) 3.2 to \</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With European League Against Rheumatism (EULAR) Good Response Baseline, Weeks 24, 48 and 72 Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. DAS28 was calculated by following formula: (0.56\*√TJC)+(0.28\*√SJC)+(0.70\*ln ESR)+(0.014\*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28\</=3.2; reduction of DAS28 \>1.2.